196. Beyond the Red Tape: Greg Jaffe on Policy as an Accelerator for Bio-Innovation

Greg one bad apple, could ruin the industry for everybody if we had an innovative food ingredient and that got people sick and it wasn't properly regulated, then that might kill the whole industry moving forward.

Karl Hey, Ram. What's going on?

Erum just enjoying the summer days. I know you've been traveling. I'm heading off to the Finger Lakes in a couple of days, actually tomorrow,

Erum But what's going on with you, Carl?

Karl I was in the Finger Lakes, last weekend, 'cause I was dropping off one of my sons at college. And, I'm hoping to take next week off and then we'll be doing a little bit of traveling in upstate New York.

Karl and really looking forward to just decompressing, deconnecting a little bit, and then coming back full force that first week of September. Labor Day is late this year. What are you gonna do in the Finger Lakes?

Erum I'm just gonna hang out with my friends. We've got a beautiful cabin, and want to read more.

Erum I mean, I'm still going down that Mike Levin rabbit hole. [00:01:00] Did you read that article, by the way?

Karl So I read it, and I still don't feel like I'm qualified to comment on it. but I think- It is

Erum deep ...

Karl it's a deep article, considering it's New York Magazine. I highly recommend our listeners check it out. I'm gonna read it again and maybe even try to summarize it in, like, a couple paragraphs and throw it into a newsletter or something, 'cause I think it's worth it.

Karl Mike Levin has a lot of deep thinking, and it gives us some good background on him. And if you haven't listened to the episode with Mike Levin, you should.

Erum Yes. The episode, the article, we'll put it all in the show notes, and it's just a lot to think about. I'm already going down into this deep hole of like, wait, what is, what is reality?

Erum What is real? But it's, it's great, and we'll have to get Mike Levin on again or his colleagues. ... So if you ever listen to Mike Levin,he's always very, generous with his, acknowledgments. He acknowledges everyone he works with, all the collaborators, everyone [00:02:00] that he's learned from, all the people that came before him.

Erum He's like, "Well, this is this person's work, this person's work." And, and so I really love that about Mike Levin,

Erum the humility. He's humble. but beyond that, it's just, uh ... It's very ... It's dense, but there's something wonderful about to be revealed, and he's definitely gonna win the Nobel Prize soon, as soon as he makes that final breakthrough.

Erum Although a lot of his work is just phenomenal already, like just based on his current work, you know, with the tadpoles, the xenobots, everything. but we'll keep you posted and maybe we'll get some of his collaborators on to talk about their specific work with Mike Levin too. It'd be great.

Karl I think that's a great idea.

Karl So as we went to record this morning, there was some big news, from Moderna. Did you see this, Erum?

Erum Yeah, you just flagged it for me, and wow. I mean, it's, uh, very amazing. Why don't you give us a summary? O-

Karl okay. So Moderna, as you know, is a vaccines company, and they've been collaborating with Merck on a cancer vaccine.

Karl That was really the first thing that they [00:03:00] started working on. And in the news today was the results of a trial that they've done with Keytruda, which is a, immunotherapy.

Karl And this combination regimen of the Moderna vaccine plus Keytruda met a goal in this study to significantly extend the time patients lived without melanoma. So this is a melanoma or skin cancer vaccine. And, this combination therapy was much more effective than just Keytruda alone. As a result of this, the Moderna stock was up 100%, which is the reason why I flagged this.

Karl And, it also showed-- that, this treatment, Keytruda plus the vaccine, reduced the risk of cancer spreading to distant parts of the body. So really, really amazing science, really amazing results. kudos to both, Moderna and to the Merck people on this study. I'm really looking forward to seeing what else Moderna does on the cancer vaccine side of the world.

Erum Yeah. We've been waiting for this. You know, I've been an advisor for the Merck Digital Sciences [00:04:00] Studio, so being able to see some of the developments at Merck, although the work that's a part of the studio is to support different startups in the intersection of AI and biotech.

Erum but this has been an effort of Keytruda being a part of this combination therapy, and whether it's a vaccine or other molecules. And I think this really goes to show that, biology is complex. It requires different types of treatments. It's not just, you know, one small molecule, one target's going to solve everything.

Erum I mean, that's what a lot of pharmaceutical drugs have been, framed as, or that's what the pharma industry, just one molecule to one target. But biology is very complex and requires multiple molecules. I think we're gonna see a lot more combination therapies because of this. This is a signal.

Erum I think a lot of pharma companies are trying to work towards this. And I always think about food as medicine, and food has multiple molecules

[00:05:00] interacting, right? Like when you, take vitamin C, it shouldn't just be vitamin C, it should be other vitamins to help with the efficacy of vitamin C, right? So, when you're eating an orange, it's not just vitamin C in there.

Erum There's multiple molecules working together so that the vitamin C is absorbed and working properly. But I think also with, AI coming on board and helping us navigate biology better, it will serve up more opportunities to have combination drugs or multiple molecules to treat certain diseases.

Erum So this is very exciting. I am very happy for this outcome, and I can't wait to see more people healed. That's really, in the end, we want everyone to be healthy and live longer, healthier lives. So I'm excited for that.

Karl Yeah. I mean, I think what you're saying also highlights the fact that there's so many drugs that don't make it out of phase one or phase two trials, those really early stage ones, and there's a lot of drugs on the market.

Karl And so then the question is: Which of those phase one or phase two

[00:06:00] failures could be revived? And then of the drugs that are on the market, which ones could be put into combinations that become new therapies for things that continue to be underserved or under-addressed? And I think that AI is probably gonna be one of the big unlocks for that because it allows us to really look at human biology differently and to really maybe go back and look at some drugs that are, 10, 20, 30, 40 years old and figure out how to use them in combination with something else, maybe to treat things that haven't been treated before.

Karl So I'm very excited about this.

Erum Yeah. Yeah. And I also wanted to say, Keytruda, when it first came out, and it was a blockbuster drug. generated over $40 billion in revenue to Merck a couple years ago. Now it's about $25 billion. But the strange thing is, is that 70% to 85% of the cancer patients did not respond initially and eventually developed a resistance to Keytruda, which is a PD-1 inhibitor.

Erum So if you think about that, [00:07:00] so 85% of $40 billion didn't result in an outcome. crazy ... that's crazy because that, that was a single drug, a single molecule. But now it's going to be interesting to see how much more efficacious you know, values-based healthcare, like there's actually an outcome happening with this combination therapy, that would increase efficacy of Keytruda to cancer patients.

Erum So I'm excited to see, and see that part, but it's amazing to see- How much money is made on drugs that don't work.

Karl Yeah. Well, it does work, it's just efficacy is limited, let's put it that way.

Erum Yeah, so it did not work in 85% of cancer patients, let's say that. So, sometimes they don't, and they're just, prescribed because it did work in a certain population.

Erum And it's just so hard to develop a drug, but hopefully it becomes easier and easier as we have new tools.

Karl All right. So then let's switch from drugs to the climate and some fun stuff before we get into our interview. listeners may remember [00:08:00] that we spoke with, Mari Granstrom,

Karl of Origin by Ocean several episodes ago, and, her company develops products for the beauty industry by extracting, molecules from Sargassum, which is a algae, seaweed, that,is problematic in parts of the world. And there was just this article talking about how Sargassum has become a huge problem in Miami.

Karl Did you see this, Erum?

Erum Yeah, that is... The pictures are incredible, just the mounds and mounds of Sargassum on the shores of Miami Beach. And you see people laying on the beach, and it's just a wall of Sargassum right at the shoreline. I'm just like, Mari, if you're listening to this, you have a lot of work to do.

Erum you have a huge feedstock Miami's a cool place to go. I haven't been in a while, but hey, go to Miami and then pick up some of this Sargassum, please, and make some more beauty products. Ugh, love that.

Karl Yeah. Apparently, you know, [00:09:00] Miami is spending something like $3 to $5 million a year to clean it up.

Karl And in Mexico, they're spending 115 million to combat it, including, deploying ships that scoop the seaweed out of the water. The question then is, like, then what are they doing with it? We know what Mari is doing with it, but what, what is Miami Beach, what is the, Dade County doing with the Sargassum that they collect?

Karl Do they just put it into a landfill? Do they just dump it back in the ocean? it doesn't tell us what this is. But this is very much a climate change-related problem. The water is getting hotter. As a result, you have more of this algae growing, and people have to address it. You know? they're not letting it just sit there

Karl So, huge opportunity for Mari and her team.

Erum Yeah, and, soon too, because I'm just seeing in this article this excessive amount of Sargassum is taking oxygen out of the water, and it's creating odors of hydrogen sulfide, which presents a human health risk, so that's another, reason for urgency here to, [00:10:00] to fix this problem and-

Karl Yeah

Karl And Carl, one other thing I wanted to flag was this amazing brand activation by our friends at K18 Hair. Did you see the big hair ball just rolling through New York City?

Karl I did see it. It was pretty scary, to be honest.

Erum Ooh, yeah. At first I'm like, "What is this?"

Karl Yeah, no, when I saw it, I was like, "What is this thing?" And it's kind of funny to see the video and to see people's reaction as this huge hair ball rolls down the street, particularly under an elevated train track. And, I think I would be pretty scared if I saw this hair ball running down the street.

Karl And K18 did this as an activation for their new longevity brand, right? for IQ?

Erum Yeah. for Future IQ, which is, proven to slow down premature hair aging, especially for the 25 to 45-year-old group, and deliver 19,000 more hairs for more volume after 12 weeks of regular use, with [00:11:00] 70% reporting fewer grays I believe it.

Erum I mean, K18 has been using biology as their North Star. They're very data-driven. They're creating these peptides that actually work. So I believe that, all these outcomes are there. I mean, they have amazing before and afters. I need to get my hands on it. I have not yet, but I will. but I just think this whole idea of brand activation is so amazing because it just gets us away from our screens and into the real world.

Erum I mean, obviously we saw it through a screen, and I have not seen it in person, but if, like you're saying, if you were to see it in person, you'd be like, "What is that?" I kinda wish they put some, like, googly eyes on it. Like, huge googly eyes would've been awesome. That's my two cents. Sabine, if you're listening, I would add that note.

Karl Yeah, I recommend that people watch it because it, this hairball rolls down the streets of Manhattan, and it does show a lot of reactions from the different people who actually got to witness it. Some people walk by it like New Yorkers do and completely ignore it, and yet other people [00:12:00] react and, there's a woman who very distinctly sticks out her tongue to remind us how gross hairballs are.

Karl And, then it ends up at the end with a small ad that says something like, "Hair should stay on your head," which, you know, speaks to the brand itself. So I think super smart brand activation. Congratulations, Sabine, on, I think, what's gonna be another winning product.

Erum Yes. Awesome. Okay, and link in the show notes for you to see the video.

Erum and so yeah, we wanna also give a shout-out to a fan that called us. We just love our phone calls. People call in and, share their love for the podcast.

Erum so shout-out to Franklin Shang, a fourth-year biomedical engineering student at Columbia who listens to the podcast in between lab experiments and just wanting to learn more about what's going on, what's, how are we growing everything, and it was just a very heartfelt note, and we wanna thank Franklin for sending that note.

Karl Thanks, [00:13:00] Franklin. so with that, why don't we get into today's podcast? Today we're excited to be speaking with, Greg Jaffe, and Greg Jaffe has spent his career at the intersection of biotech and policy. he was the USDA's chief regulatory officer and senior advisor for regulatory affairs during the Biden administration, where he led the department's work on the bioeconomy.

Karl So he was, instrumental in implementing the Biden bioeconomy executive order to coordinate research, infrastructure, and markets for bio-based products. Today he's running his own consulting firm, and he's advising bioeconomy teams internationally. So if you want to understand what biology as technology means and how it moves either as fast or as slow as it does thanks to regulations, listen to this interview with Greg

Karl Greg [00:14:00] Jaffe, we are so pleased to have you on the "Grow Everything Podcast." Welcome to the podcast.

Greg Well, thank you very much, Carl. I'm excited to be here.

Karl We're really excited to have, this conversation with you because you're gonna bring a different point of view when it comes to the bioeconomy and what is happening on the regulatory side.

Karl So let's just get some background. You started your career as an environmental, attorney for the Department of Justice and then the Environmental Protection Agency, and later you spent years at a consumer watchdog organization before you became the USDA's chief regulatory officer,

Karl What was the catalyst that made you transition from litigating environmental cases to shaping a national policy framework for the bioeconomy?

Greg thanks for that question, Carl. to answer it, I really need to go back a little bit. for my whole adult life, I've always been interested in how science and technology forces changes in laws and regulations.

Greg So in college, I double majored in biology and government, and I wrote a thesis in both departments, which I don't think anybody had ever [00:15:00] done, entitled "Recombinant DNA: The Question of Regulation." And that was before the government ever published the coordinated framework. so I'm dating myself a little bit.

Greg and then I went to law school, and so I became an environmental lawyer because I thought that was a way to combine my interest in science and law, and it was, really exciting. You're representing the US government, getting up in court and saying, "I represent the US government," and getting polluters to clean up.

Greg But, as I worked in that career, I found out I spent most of my time fighting with other lawyers over legal procedures. I never got down to how much was pollution or how do we clean up this pollution? It was more procedural stuff, and that didn't excite me. So little by little, I moved more into the policy space, and I always wanted to get back to that biotech r-roots that I had, that biology roots.

Greg And so a job opened up at the Center for Science Public Interest to run their biotechnology project, and I moved there and became a biotechnology and food expert, which I Didn't have much training in ag at that point. and so I spent, 20 years doing that, and that [00:16:00] got me really engaged in biotech crops and genetic engineering and how do we regulate these things.

Greg And so it was natural when Secretary Vilsack at US Department of Agriculture asked me to come on as the chief regulatory officer, that I jumped at that chance. I had that experience as this sort of Washington regulatory administrative person both inside and outside the government. But then I also had this biotechnology background, and so I ended up leading our work on bioeconomy.

Greg And parts of that I had lots of knowledge and experience about, and others, such as biofuels or woody biomass, some of those things I learned when I got to USDA. And so I became that broader lead for the department in that whole bioeconomy

Karl That's amazing. So we talk on this podcast about how people use biology as technology to really reformulate and change the way we make things, and we do see that it's changing agriculture with things like gene-edited crops and fermented proteins.

Karl From your regulatory vantage [00:17:00] point, is the current, coordinated framework for biotechnology undergoing a gradual evolution, or are we hitting a wall where the rules just can't handle how quickly biomanufacturing is moving?

Greg So I think I can't give you a yes or no answer.

Greg what I can say is I think that, when you look back at the coordinated framework, I think the principles that were articulated in that framework are still very applicable. The ideas that we focus on the product, not the process by which it's made. That we make sure the regulation is proportionate based on the science and the potential risk.

Greg That we use existing laws and not adopt new laws. We can't really pass a law every time there's a new technology or a new product. That takes too long. and that there should be coordination among the agencies. We should look to different agencies who have different expertise and utilize that instead of putting everything in one agency and having them learn the expertise in it.

Greg So I think those principles still carry really well through to today. But I think you hit the spot when you said, "Can it do it fast enough?" And the

[00:18:00] problem is biotechnology and the products are moving very, very fast, and regulation just can't keep up with that. and the government, can adapt those regulations and laws to those new products, so that slows the industry down.

Greg And I think that's where the problem is. and there are ways to address that. We can increase transparency. I spent a lot of my career in the federal government, and there are amazing career people, and they're great scientists, but They're never gonna be as up on the science as the industry is.

Greg They're always gonna be one step behind. And so the more transparency the industry has in terms of publishing papers and coming in and consulting with them and inviting them to conferences, the closer they can stay to the science. But then you need the resources from the government to sort of adopt and, I think what was great about the coordinated framework was it was able to adopt these laws that weren't meant for biotech and adapt them so we didn't have to have new laws.

Greg Europe had new laws, and that takes forever to implement. so I think, we have some good things [00:19:00] there, and we need to sort of work with the good, and we need to supplement in terms of resources and transparency and technology to keep regulators as close as possible up to what's really going on.

Karl And just so our, our listeners understand, when was that coordinated framework for biotech passed? Do you happen to know?

Greg Yes, of course I do. It w-wasn't passed. It was a, it was published in the Federal Register. It's just an executive, document. In fact, it has no legal authority because all it says is, "We're gonna rely on all these other legal authorities."

Greg So it's a, executive, policy first adopted in 1986 And it's been modified. I think 1989 we had one modification to it, and I think it was 1997 maybe we had a second one. so we've had instances where we've sort of revised it or, or updated it a little bit, but it's kept with those same principles, from the beginning.

Karl Yeah, that's amazing. So before we get into, kind of more legal tech stuff,

[00:20:00] can you help our listeners visualize what your work was like when you were at the USDA serving as chief regulatory officer? and I'll set this up a little bit so you can help our listeners understand. if an early-stage biotech startup wanted to get a novel bio-based product to market, what's the gauntlet they have to face across USDA, EPA, and FDA, and what would it look like for a company, for example, that's producing food dyes from engineered E.

Karl coli or yeast?

Greg so that's sort of two separate questions. So USDA is a big agency. It was, when I was there, it was 100,000 employees. It's now 80,000 employees. And in some ways, we consider it, the really Department of Rural America. I mean, it does agriculture, but it does so much more.

Greg It has the Forest Service in it. It has all of our nutrition programs are in USDA, and it has a big role in rural communities, whether that's internet, utilities, water systems, electricity, a host of different things. so as the chief regulatory officer, my role was to make sure that our major [00:21:00] regulations, we had a regulatory agenda, every agency had a regulatory agenda every year, got published.

Greg and that involved engagement with the Office of Management and Budget at the White House and all the other agencies. So before any regulation gets published in the federal government, to ensure consistency, we let all the other agencies take a look at your regulation and say, "Okay, EPA, does your regulation is consistent with what USDA's policies are?"

Greg and so forth. And so my job was to manage that inter-agency process for all of our major regulations, whether they was about food safety, whether they were about the Forest Service, whether they were about SNAP, the supplemental nutrition programs. and so that was to do that, as well as engagement with the other agencies, such as EPA or FDA or Department of Interior, on regulations that they were publishing that had impacts on our stakeholders or on our programs.

Greg So that was sort of the job as chief regulatory officer. and again, I came in with some [00:22:00] expertise in certain areas. I had not done anything with the Forest Service or conservation. And so, I'd done a lot on food safety. so for me, I learned a lot, but the same principles apply on how do we deal with administrative law and how

Greg a lot of it's negotiation. How do we make sure that we're being consistent in the positions that the government's taking? So it's a good process. It takes some time, but I think it is valuable. So if a biotech startup now wants to, have a product in the marketplace, my advice always has been to come learn about your federal regulatory pathway as early as possible.

Greg I know some companies don't want to come until they already have, more than proof of concept, and they're already part of the way to understanding, designing their commercialization process. But the earlier you come in, the better you are because you can then adapt your process and your production system to the regulation.

Greg You can then potentially decrease the regulatory burden that you might have, as opposed to making a decision without knowing what the regulatory impacts of those, that [00:23:00] decision are. So if you had a decision tree, if you're a biotech startup and you're thinking, "Oh, should I use this organism or use that organism?"

Greg Well, if you pick one organism that FDA is very familiar with, that may reduce your regulatory If you pick a different organism, and nobody knows anything about that organism, well, then you're gonna have a much bigger regulatory burden. so sometimes knowing these things early really helps.

Greg But what I always say is, to start up with,we could have a biotech product could be regulated by one of those three agencies, two of them, three of them, or none of them, depending on the product. And it depends not just on the product, what you're producing, but it also depends on your intent.

Greg How do you intend to use that product? I think companies don't always understand that a lot of our laws are intent-based, and so a pesticide is something that intends to kill a pest an insect or a fungus or something. But there are many different chemical and biological compounds that might kill a pest, but if you don't market it as killing a pest, then it's not a [00:24:00] pesticide.

Greg a, aexample I can give for people is, antimicrobial hand washings. If you say it has antimicrobial properties, if it's going to kill bacterium, then it becomes a pesticidal product. If you just say it's going to, be really good at cleaning, cleaning your hands, and getting off dirt and other things, then it doesn't become, even if it has antibacterial properties within it.

Greg so intent is very important. So if we look at your example of the microbe that's gonna produce a food coloring or a food dye, it's most likely gonna be regulated solely at FDA. and FDA has a specific pathway for a food additive coloring process, a regulatory process that's a mandatory process that you must get approval for.

Greg But at the same time, if you happen to be engineering that microbe to produce that food dye, and you've used plant pest components in the DNA that you've introduced to it, well, then you might also be regulated by USDA because USDA's Animal Plant Health [00:25:00] Inspection Service regulates plant pests.

Greg So that's why you do have to get into the details sometimes. And so it depends not just what is the product, what is the intent, but a little bit about the process. What did you do? How did you get to where you are? Does make a difference in terms of what regulatory pathway you might have.

Karl So I think that the important lesson for our listeners is if you're building anything with biotech, better to, engage regulatory earlier rather than later.

Greg Yes. I think that is just critical because I do think that you can, again, I, don't want to say design,But you can design to reduce your regulatory burden, whether that's in your product design or whether that's in your commercial production process or your, commercialization pathway, your business plan.

Greg and so thinking about those things might lead you to to make a different decision. I give an example of a company that is trying to raise money for a food ingredient and they put a health claim on their website. And then I say

[00:26:00] to them, "Well, if you put a health claim in it, you had a much bigger burden at FDA to getting that product through the regulatory process."

Greg They're like, "Well, we're not gonna... In the end we won't make that claim." I'm like, "Well, you've already made it. It's on your website." So that's out in the internet. You can't, get rid of that. so I think sometimes you can, you know- Cause yourself to have increased burden even inadvertently not knowing about it early in the process.

Karl Yeah. So you spent, years, representing consumers at the Center for Science in the Public Interest, which is I guess think tank that I admire a lot. I think of them as being a think tank. Correct me if I'm wrong.

Greg A think tank/advocacy organization. They do both

Karl So when you had to switch sides and move to the, federal government, what were the lessons that you took from that advocacy work that made, working in that federal government bureaucracy easier to manage?

Greg So I'm gonna push back a little bit on your [00:27:00] wording. I wouldn't say I switched sides. Yeah. I think we're all trying to do the good, I think industry, NGOs, the government, everybody has the same goal overall in the end. We wanna have safe products that are out there that are, that consumers wanna buy, that utilize our resources in a sustainable way and so forth and so on.

Greg so what I think I took from that work, I mean, I think it's really important that our government officials have experience in NGOs and industry, and, that was very valuable to me. One, you understand how the other side or other players, stakeholders are thinking, and so you can take that perspective.

Greg And while you're in your internal deliberations phase within the government, whether you're deciding on a regulation or approval, you can play that devil's advocate. You can say, I know that CSBI or, The Nature Conservancy or somebody's going to raise this point. How do we address this point?"

Greg And so we can make, the proposals much stronger from the beginning when you have [00:28:00] people who have come from that perspective. And the second thing, I think, is that you become a better listener also. part of your role in the government, and especially at the level that I was at, is really to listen to the different stakeholders.

Greg And so having been a stakeholder and been on the other side of the table, I think you understand how important it is to listen and to listen to everybody, and to then take everything you take in from those sessions and really digest it and figure out where are the solutions, where is the balancing, where can we get a good decision.

Greg So I think those are the two things that I really took from it.

Karl That makes sense. given your background, I think it's super interesting to be having this conversation now because there's a lot of issues with the public trusting science, and we've seen places like Florida, preemptively banning cultivated meat even though they're not even on the market yet.

Karl But public trust is often the silent killer of brilliant innovations, particularly biotech or biological innovations, especially when it comes to things that people eat. That's why I mentioned Florida. [00:29:00] How do we build a regulatory system that's rigorous enough to assure skeptical consumers that biomanufactured food is indeed safe without choking off the innovation?

Greg So that is the key question, as a regulator, as a member of Congress, and even in an industry and others, how do we get that balance? How do we get the balance between ensuring safety, to humans, safety to animals, safety to the environment, with innovation and allowing innovation to move forward?

Greg and I think, that's something that we're constantly balancing, and it is a trial and error to some extent. it doesn't always fit neatly into it. and so, I think you need to have regulation because if you don't have regulation,one bad apple, could ruin the industry for everybody.

Greg if we had an innovative food ingredient and that got people sick and it wasn't properly regulated, then that might kill the whole industry moving forward. and so, we see that a little bit in the biotech engineering of crops. We had some issues at the beginning, and those caused lots of [00:30:00] problems, although they weren't necessarily safety issues, but they maybe were transparency or other issues.

Greg and so I think, oversight is important, and it's important to have some level of precaution to it, but we really have to balance, make it proportionate to the potential risks of the different products and not let it become overly burdensome. and so that's where I think we have to manage it.

Greg any first of its kinds are always gonna be a little slower, and I know that's very frustrating to the industry, and that's partially 'cause the government is playing catch up and trying to figure out what to do and get there. and especially with things like food, where food is cultural, religious, for family, for other kinds of things, consumers tend to be fairly conservative and tend not to jump in to do that.

Greg Overall, I think, generally on biotech, whether while we can say that the regulations could be streamlined, could be better, we do a better job than many other countries, than the EU and other countries, at doing that balancing and trying to get products that are familiar, that are similar to products that we have in the market that have a lot of [00:31:00] familiarity to us, that have low risks.

Greg We try to move them quicker through the regulatory system, but we also then hopefully leave the resources for the first of its kind, the new things that need some additional scrutiny. so I, I don't have a good answer other than to say, I think the US is doing better than some others. Does that mean we can do better?

Greg Yes. and we should continue to strive for that, but I do think that you need to balance that for public trust, for markets, and for a host of other reasons.

Karl Well, speaking of other countries, you have worked with international stakeholders in sub-Saharan Africa and Southeast Asia to help them develop their own local biotech laws.

Karl How do you see the perception and regulation of the bioeconomy differing between the United States and developing agricultural markets?

Greg So I guess I can answer that several different ways. I think, In the US, we're obviously, we are a technology-forward [00:32:00] country, and so things biotech crops and biotechnology and bioeconomy has been more embraced by our farmers, by the supply chain, even with the questions of things are moving slower than maybe you or I might like.

Greg On the whole, we do embrace these things. And more importantly, our regulatory systems, not only do they ensure the safety of them, but our federal programs really de-risk many of the issues of bringing those to market. So we de-risk farmers for new inputs that they might want to try. we de-risk farmers who might,wanna try a different crop.

Greg We have crop insurance. We have other kinds of things. And sometimes I think we don't realize that other countries don't always have those, especially in developing countries and places like that. And we de-risk, other parts of the supply chain. We give grants, we give loans, we have tax subsidies, a host of different things.

Greg And maybe, again, maybe not enough, maybe not prioritized enough, but we do do some of that. And so that allows our perception of biotech and our

[00:33:00] ability to try the benefits to move forward. When you move to countries in sub-Saharan Africa or Southeast Asia, they have several issues. One, they don't have the same technical sc-scientific capacity, so they don't have the ability to develop these products themselves.

Greg A lot of them are being imported. And when you're imported, there's always a little worry that, is somebody importing something that's not so safe? There's a history of,countries in the developed world dumping things into the developing countries that have,and have had lots of impacts on those environments and other things.

Greg so there's a little bit of a skepticism. and they don't have the capacity to regulate. They don't have the scientists and the lawyers and things. And so one of the things I did for many years was help build that capacity, give them the tools to do that. But the other thing is, if you don't have your own scientists doing it, if you don't have a product in the pipeline ready to be utilized, it's very easy to develop precautionary regulations.

Greg Like even you mentioned cell-cultivated meat and some of the regulations in places like Florida. if there's [00:34:00] no product that consumers want and no product on the market, it's easy to ban the product.

Greg Okay? Yeah. I mean, 'cause you're not, you're not impacting anything.

Greg And similarly, in places in Africa and Southeast Asia, if they don't have a product, a Bt eggplant or something that their farmers could utilize tomorrow and know what the benefits are, it's easy to be precautionary in your oversight of that. And so we've seen a lot of that. And so this has to be a movement from the ground up.

Greg You really have to have the capacity in those countries. They have to be developing locally adaptable products for biotech or bioeconomy, and then they build the support for those And so I think if you do that, and then if we can figure out a way to help de-risk those things, they will embrace this tremendously.

Greg But that's a bigger hurdle in those countries than it is in a place like the United States.

Karl Yeah. And what's interesting about that is that biology is universal and,and biotechnology, as it becomes easier to access, means more people, even in those developing countries, will have access to it.

Karl So I think we [00:35:00] need to have a regulatory system, and they have to have regulatory systems that anticipate the kind of, you know, change that we're gonna see with this technology.

Greg Right. And I, I mean, one of the things I always said with genetically engineered crops, but I think it holds true for many different bio applications is they're really scale neutral.

Greg I mean, you can do them at small scale and get benefit from them. You don't need to have very large scale necessarily. You can adapt them to small scale situations, and you can see immediate benefits.

Karl So before we did this podcast, you shared, a talk that you gave recently about how biomass and biomanufacturing are inherently local and

Karl What they do is they create a need for a bottoms-up approach to policy. What's the biggest challenge in trying to marry hyperlocal farming with massive centralized federal regulations or a federal regulatory system?

Greg I actually think they complement each other.I do honestly believe that biomass is inherently local.

Greg it's heavy a lot of times.It is hard to transport far in, large [00:36:00] volume. You're not gonna produce biomass in the United States and send it off to Europe to be processed or something like that. Right. you're not even gonna send it to the East Coast from the Midwest. you have to process it there.

Greg so you have the biomass there, and it's obvious then to have the biomanufacturing there, and I think you can build a community there, and then it helps rural communities. It helps the farmers, it helps,the people who transport it, the whole system there. So you set up the infrastructure you need to have the workforce and everything else.

Greg So I think that's inherently local, and that needs local policies, local partnerships, local, governments getting engaged and giving incentives and so forth and so on. Where I think the federal go-go-government comes in it sets up the broader national enabling environment for that and sets up the national policies that can help allow those local, initiatives to flourish.

Greg And, examples of that would be, again, some of these de-risking programs that allow farmers to de-risk, new crops or new things that give them, funding for those type of things. It could [00:37:00] be tax incentives for sustainable aviation fuel, which allows those companies to want to build those, plants in those local communities and understand that they have, a national thing.

Greg And it even is regulations, because if there's not a pathway to market for a national pathway to market, w- you don't want products that have to be regulated on a state-by-state basis and have states do it and have different states, either coming to different determinations about the same product or even just having different requirements for those same products.

Greg so there are roles for the national government in setting the overall structure and the overall I call it the enabling environment, which is policy, incentives, a host of different things. but yet at the end, it is the local stakeholders, the local partnerships that really drive this because the federal government doesn't have control over, of those farmers and of that local biomass.

Greg that's really done at the local level.

Karl Yeah, that makes sense. So you run a consulting firm, Jaffe [00:38:00] Policy Consulting, and you advise companies that touch on everything from PFAS and pesticides to sustainable proteins. What specific bio-based sector do you think is currently the most prepared to scale commercially, and which ones are lagging because regulations are ambiguous?

Greg so I first want to say that I, I look at regulation as enabling. I know some people look at it as stifling. I look at it as enabling because it enables public trust, it enables supply chain trust, it enables markets, it, enables international trade and a host of other things. but I do agree that it is one of the hurdles to getting products to market.

Greg I don't think it's the only hurdle. I think we also have issues of building infrastructure, we have getting things at a price competitive, scale, and we have just the problem of overcoming legacy products which are already embedded into the marketplace and into companies.

Greg so I think it's one of the hurdles, I will agree with you, but I also like to give it a more optimistic slant that I think you can look at regulation as stifling or you can [00:39:00] look at it as enabling. With that in mind, I, I think for the bioeconomy products and bio-based products that I sort of follow to some extent, I think where we're gonna have the best successes are in things that are, high-value molecules that have small markets that can get to the level of production that you need to saturate a market in a very short period of time.

Greg so that could be certain kinds of specialty chemicals, for example. It could be a food dye or something like that. I think where we will have a lot of success especially is because of regulation, where products are being banned, whether they're being banned in Europe or the United States, or even being banned by the marketplace, not by a government.

Greg Like if we're gonna look for a replacement for a red food dye, for example, companies don't want to sell that anymore, either because of consumers or because of government saying it's no longer safe. That's a, a big opportunity, and there you have an immediate market if you can meet that. And I think there are some companies that are looking for those markets.

Greg So, I think those [00:40:00] are gonna be what is quickest. What's very hard, much harder, and especially in the space that I work in, some of these sort of chemical and food ingredient spaces, is where you have more commodity Items that really need large volumes and are at low cost, And so you really need to really have very large volumes, which requires real big infrastructure, and that's just gonna take a lot more time, and it's harder, again, to penetrate and replace legacy ingredients or legacy chemicals.

Karl Yeah. Yeah, I, I mean, you mentioned,what's gonna be easy, and specifically you mentioned potentially like these red dyes because of, disinterest in removing synthetics from food, which I think is across the board, not just with colors. But there's been a lot of interest in this Make America Healthy Again movement and its implications for the American food supply chain.

Karl How do you see shifting health and wellness priorities trickling down to affecting policy for farmers or for [00:41:00] shelf-stable food technologies?

Greg So, I mean, I think the MAHA movement is here to stay. maybe not in the same incarnation that it is, or maybe not with the same political actors, but I think, people are much more conscious of their food and trying to eat healthier and do that, and I think that's gonna be a continuing movement.

Greg and so I think any purchasing by the consumers trickles back down to the farmers, and if certain things are not gonna be purchased, that will trickle down and affect farmers. And so I think we will see winners and losers in the supply chain and in farmers. We will see maybe some switching of crops or some reduction in acreage of certain crops and increases in acreage in other crops.

Greg I do think there's an opportunity here. There's always been a concern that, we were growing too mu- too much corn and soybeans for biofuels or for bio based products, and that somehow we were hurting food security or hurting that type of thing. I think now we may have more opportunities to use some of the traditional crops that may now [00:42:00] be less used in the food supply to utilize them more for bio-based products.

Greg So, I can't predict who the winners and losers are, but I can tell you there will be changes.

Karl Yeah. Well, that's the only constant, right?

Karl so looking ahead 10 years, what role do you think federal policy will play in the global bio-economy, and what needs to change right now to make bio based products the economic default for businesses rather than a heavily regulated alternative?

Greg So I think, I think federal policy will p-play a major role in us achieving, a bio-based economy and have more bio-based products. I think, there are probably a number of areas where we do need to have, the federal government engage with. One, I think we've talked about a lot is the regulations.

Greg We need more streamlined, predictable, timely, fit for purpose regulations for many of the bio-based products. If we don't get those, we will lag behind. I think the government, as I've mentioned earlier, has to really invest in de-risking the pathway to commercialization, whether [00:43:00] that's helping farmers to try new inputs, whether that's loans or grants to build infrastructure, whether that's long-term tax incentives.

Greg I mean, it's great we have a 45Z tax incentive for sustainable aviation fuel for three years, but, let's be honest, these plants are gonna cost a half billion to a billion dollars. You need a 10, 20 year tax incentive to really do that. the government, I think, has been really underutilized in playing the demand role.

Greg So I think, you can use the federal purse to be that demand pull, and we haven't done that. I mean, I was involved with the BioPreferred program, which is one program at USDA that tries to do that. It's a great program, but amazingly underutilized. And so using whatever we can, federal purse, California state purses, educating consumers, we've got to build that demand.

Greg and then the fourth thing is I do think it's a global market, and so we have to be engaged in the international discussions around this. whether it's setting definitions and setting [00:44:00] metrics, whether it's ensuring that these products can cross borders, because if bioeconomy products are gonna be successful, they have to, make the money they need to do and have that, positive balance on their spreadsheet.

Greg They need to look at the broader global market, and so there has to be access to that

Karl Yeah, that totally makes sense and I agree with you. so we've reached the part of the podcast where we're gonna just ask a bunch of kinda quick-fire questions. I'm just gonna ask you, quick five questions.

Karl What's one biotech myth floating around Washington that you wish would disappear forever?

Greg you don't hear it as much these days, but the myth somehow that genetically engineered crops are unsafe to eat. You'll still hear that occasionally. Yeah. People still have this view. I think there's evidence that's overwhelming about that.

Greg They've been grown for decades. A correlate to that is somehow that organic is healthier, which I also think is a myth because, it's not true. I mean, we want people to eat more fruits and vegetables, whether they're genetically engineered or organic or anything, [00:45:00] but, an organic soda pop is no more- healthier than Coca-Cola.

Greg And so- Yeah ... the devil's in the details for both of these things.

Karl Okay, so if you had to describe the relationship between the USDA, the EPA, and the FDA using one word, what's the word you'd use?

Greg So the word I would use is complicated. So I think, on one hand, there's a lot of collaboration between the three agencies, especially at the career level.

Greg They share science, they share information, they really work together when they, when their regulatory authorities overlap and everything. But at the same time, they have different mandates, and those mandates can conflict. I mean, USDA's, one of its roles is to really help American agriculture. but yet EPA is the one who regulates pesticides, and sometimes they regulate pesticides that cause...

Greg making agriculture more difficult ... for farmers. FDA and USDA both regulate different parts of the food supply. They try to make those regulations consistent, but they're not always consistent, and [00:46:00] sometimes the burden is higher on one type of food than a different type of food. so that's why I say it's complicated, because I think they work well together, but they also inherently have, parts of their mandates that do conflict.

Karl Yeah. What is the single biggest policy red flag that tells you a biotech startup has no idea how Washington works?

Greg So I'm gonna give two flags. I hope that'll be okay. One is that the company assumes that those in Washington understand biotechnology and that they don't need to actually educate them about it.

Karl Right.

Greg wherever you are, you gotta start three steps before that, because many policymakers, whether they're on Capitol Hill or even in the federal government, in their senior level, just don't know a lot about this topic. And the second one is that somehow if you just do everything whether you're in Boston or Northern California, something like that, if you sort of just apply that you're gonna get your answers from USDA, you need to engage, you need to consult, you need to spend some time investing informally with the government if you

[00:47:00] really wanna move forward.

Karl Absolutely. What's one food or climate solution being pushed by policymakers that you're deeply skeptical of?

Greg So I would almost say any one policy from the MAHA movement. And the reason I say that, let's take ultra-processed foods or eliminating artificial dyes, specific dyes. Any one of these, that might be helpful, but if the goal of the MAHA movement is to make America healthy again and to eat healthier diets, that really is a food systems change.

Greg You need to have multiple things. And so getting rid of one dye isn't really going to make us healthier or putting a definition on ultra-processed foods alone. We need to have education and a strategy and really a change in the way we grow food and the way we process food and so forth.

Karl Makes sense. Okay, so let's, end with this one. Finish this sentence, "The future of the global bioeconomy will be built by..."

Greg by using local biomass, biotechnology innovation, and local biomanufacturing [00:48:00] capacity to produce bio-based products that, that replace legacy products.

Karl I couldn't have answered it any better than that. I agree with that one 100%. So Greg, thank you so much for coming on the Grow Everything podcast. We really appreciate you taking the time. we'll look forward to catching up with you and hearing how things are going forward with, your work.

Greg Well, thank you very much. It's been, a very, a good set of questions, Carl, and I've really enjoyed doing this.

Erum So Carl, that was an amazing interview. I was so sad I wasn't able to join that interview, but wow, what a great conversation. What did you think? What were your key takeaways?

Karl We talk about regulations on and off on this podcast because regulations is a part of growing the bioeconomy.

Karl And, Greg mentioned that regulation is basically the trust layer that lets markets exist. And while some people might see regulations as a block, other people are gonna see it as an opportunity. And if you're building anything in or for the bioeconomy, you should understand what the regulations are, because at some point or another, you're gonna have to deal with them.

Karl It's not just build something and put it out in the world without really thinking through what the implications are. So, I don't know, what did you think, Ram?

Erum Yeah, that's really true. I mean, I, over time, have been talking to, of course, lots of people, that are building biotech solutions, and some see regulations as [00:50:00] that roadblock, like you're saying.

Erum But, it's really a way to de-risk their company, to go through those regulations and ensure that nothing goes wrong as you roll out this product into the market so that you don't have as many lawsuits. So it's, actually a great, I guess checkbox. Like check off the boxes and make sure things are, above board.

Erum Greg's really great because, you know, he's also looking at regulation from a communication standpoint. So it's not just like molecules and like what's the data of how the molecules affect people on the planet. He says regulation follows language. And I liked the example, the hand wash example, that the same compound used in soap is called antimicrobial, but it's also a pesticide,

Erum so it's just changing the language changes the perception. And then also, I love that story of the founder who put a health claim on their website

[00:51:00] to attract investors, but by doing that, they unknowingly moved their product onto a much heavier FDA pathway.

Erum So language is super important. Like, since we do communications for biotech companies, we really have to thread that needle, making sure we create aspirational copy, but nothing that's misleading. and that's for like biopharma. In the world of, consumer biotech, beauty and cosmetics, things are a lot more gray there, and so that's been a challenge.

Erum But I think, you know, as long as we're honest, everyone's honest and not just trying to, sell product but also benefit their consumer. You know, they want to benefit the consumer, so they want to be honest. I think it's, you know, really important. Any other highlights? What else did you think, Carl?

Karl Well, I mean, it's interesting we started this conversation talking about, the sargassum problem in the Caribbean, in Miami. And, Greg made the point that biomass is local, you can't ship it too far. and [00:52:00] even said that the industry is constrained by physics to be regional. So in many cases, you know, VC is mismatched to the bioeconomy.

Karl What that means is,capital that's chasing deals in three cities might be the wrong way to approach it. So then the question becomes: What model actually works better? is it community infrastructure funds or is it regional orchestration? You know, this Miami sargassum problem or Caribbean sargassum problem, could be an example of what that looks like.

Karl What are local companies doing around the Caribbean to leverage this biomass that can be probably used in many different forms? we pointed out that Mari turns it into cosmetic ingredients, but what else could be done with that on a local basis?

Erum And another thing, finally, something that we've been talking about in so many episodes, especially during our biodye series, is the idea of the MAHA movement and that also biotech's silver bullet habit which we talked about earlier. It's like, you know, one [00:53:00] small molecule, one target.

Erum And, you know, he's saying that, there's no single band that makes anyone healthier and that there's a systems change required, which I think we're just gonna keep hearing over and over again as we learn so much from all of the tech efforts, when it comes to biotech and AI, right? AI is going to be pointing out so many different blind spots that we might have had wh- when it comes to developing solutions.

Erum And you might, be like, okay, well, you know, just like the Keytruda thing, it's like not just one molecule. You might also need, this vaccine and this other molecule and this combination of solutions to solve a systems problem. And I think it's going to be something that we see more and that, Greg flagged that every startup pitch has to have this regulatory conversation and-

Erum see how you can use it as an advantage, and in, how do you incorporate

[00:54:00] it into your pitch and your story so that it's a differentiator rather than a constraint.

Erum So I'm really happy to hear, that from your conversation with Greg.

Karl Yeah. I mean, again, it's like what we said as we were doing this commentary. you know, you don't have to look at regulatory as being a blocker. And, one of the things we do talk about with biopharma companies that have a new technology is theythey really do have to educate the regulators because their technology is so new.

Karl But doing that kind of education and working with the regulators early enough gives you that competitive advantage. That is a differentiator. So it was good to hear Greg talk about that.

Erum All right, well, next time we'll have to have Greg on and I'll join.

Karl Okay.

Erum And we'll have a conversation. I mean, just the regulatory side, just knowing all the ins and outs and what's happening, 'cause it is changing very quickly, and so it's great to have somebody on the inside to help us navigate that.

Erum So thank you so much, Greg, for joining us.

Erum so folks, thank you for listening. If you wanna hang [00:55:00] out and learn more about how biotech's being commercialized, you should join us at Bio Innovations by World Biomarkets. It's happening in Omaha, Nebraska in September.

Erum We do have a promo code for you. It's GrowEverything, and you get a 25% off discount. So save some money and come and attend.

Karl We look forward to seeing you there. So thank you for tuning into the Grow Everything podcast. If you have any questions or comments, please do reach out to us. We love hearing from our listeners and our fans.

Karl Our contact information is in the show notes, and don't forget to subscribe to our Substack. Let's grow.

Erum Let's grow